Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000864
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Study to Test the Safety Tolerance and Metabolism of Abacavir 1592U89 ABC With Standard Zidovudine ZDV Therapy in Newborn Infants Born to HIV-1 Infected Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Study of Safety Tolerance and Pharmacokinetics of Abacavir 1592U89 ABC With Standard Zidovudine ZDV Therapy In Neonates Born to HIV-1 Infected Women
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety tolerance and metabolism of single-dose and multiple-dose abacavir ABC in HIV-exposed infants receiving standard postnatal treatment with zidovudine ZDV This study also evaluates the correct dosages of ABC to be used in future studies
Early aggressive therapy may be the best chance to slow disease progression in infants who may have been infected with HIV by their mothers Early HIV suppression may significantly reduce viral levels and allow for restoration of the immune system providing improved control over HIV infection Therefore it is important that the safety and tolerance of ABC in combination with ZDV be examined as potential early therapy in newborn and young infants
Early aggressive therapy may be the best chance to slow disease progression in infants who may have been infected with HIV by their mothers Early HIV suppression may significantly reduce viral levels and allow for restoration of the immune system providing improved control over HIV infection Therefore it is important that the safety and tolerance of ABC in combination with ZDV be examined as potential early therapy in newborn and young infants
Detailed Description:
The rationale for investigation of this agent is to define the safety and pharmacokinetics in young infants to allow for investigation of the efficacy of this agent in combination with ZDV as potential early therapy in newborn and young infants The rationale for early aggressive therapy is that this may be the best chance to significantly reduce the long-term progression and subsequent impact of HIV-1 infection in vertically infected infants Early ablation or enhanced suppression of HIV-1 replication may significantly reduce total viral load and may allow maturation preservation or reconstruction of immune function at a stage early in infection providing improved control of HIV-1 infection and reduced disease progression
This study is divided into 3 sections as follows Part 1A is a single-dose study in neonates 0 to 72 hours of age If four of four patients reach the minimal therapeutic level with less than Grade 3 toxicity the ABC dose is escalated Part 1B is also a single-dose study in infants 21 to 28 days of age starting with the dose identified in Part 1A If four of four patients reach the minimal therapeutic level with less than Grade 3 toxicity the dose is escalated again Finally Part 2 is a multi-dose study to examine a dosing regimen for ABC and ZDV for neonates 0 to 72 hours of age The dosing regimen for ABC is the dose defined in Part 1A for the first 3 weeks 0 to 3 weeks of age followed by the dose defined in Part 1B for the second 3 weeks 3 to 6 weeks of age All patients receive 6 weeks of standard ZDV therapy
AS PER AMENDMENT 92497 This study is divided into sections as follows Part 1A is a single-dose study in neonates 0 to 48 hours of age ABC dose escalations are made until a dose is identified that meets toxicity guidelines and demonstrates a minimal target area under the concentration curve AUC of 2000 ng-hrml Part 1B is a similar single-dose study in infants 3 to 7 days of age with escalation as per part 1A Part 1C is an identical single-dose study in infants 21 to 28 days of age but starting at the dose identified in Part 1B Part 2 is a multi-dose study to examine a 6-week dosing regimen for ABC and ZDV for infants 0 to 48 hours of age The dosing regimen for ABC is defined in Part 1A for the first 48 hours of life the dose defined in Part 1B for Days 3 through 20 of life and the dose defined in Part 1C for Days 21 through 42 of life AS PER AMENDMENT 72998 Enrollment to Parts 1A and 1B will remain open Part 1A will enroll a minimum of 4 patients as planned and Part 1B will enroll 3 additional patients
This study is divided into 3 sections as follows Part 1A is a single-dose study in neonates 0 to 72 hours of age If four of four patients reach the minimal therapeutic level with less than Grade 3 toxicity the ABC dose is escalated Part 1B is also a single-dose study in infants 21 to 28 days of age starting with the dose identified in Part 1A If four of four patients reach the minimal therapeutic level with less than Grade 3 toxicity the dose is escalated again Finally Part 2 is a multi-dose study to examine a dosing regimen for ABC and ZDV for neonates 0 to 72 hours of age The dosing regimen for ABC is the dose defined in Part 1A for the first 3 weeks 0 to 3 weeks of age followed by the dose defined in Part 1B for the second 3 weeks 3 to 6 weeks of age All patients receive 6 weeks of standard ZDV therapy
AS PER AMENDMENT 92497 This study is divided into sections as follows Part 1A is a single-dose study in neonates 0 to 48 hours of age ABC dose escalations are made until a dose is identified that meets toxicity guidelines and demonstrates a minimal target area under the concentration curve AUC of 2000 ng-hrml Part 1B is a similar single-dose study in infants 3 to 7 days of age with escalation as per part 1A Part 1C is an identical single-dose study in infants 21 to 28 days of age but starting at the dose identified in Part 1B Part 2 is a multi-dose study to examine a 6-week dosing regimen for ABC and ZDV for infants 0 to 48 hours of age The dosing regimen for ABC is defined in Part 1A for the first 48 hours of life the dose defined in Part 1B for Days 3 through 20 of life and the dose defined in Part 1C for Days 21 through 42 of life AS PER AMENDMENT 72998 Enrollment to Parts 1A and 1B will remain open Part 1A will enroll a minimum of 4 patients as planned and Part 1B will enroll 3 additional patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PACTG 321 | Registry Identifier | DAIDS ES | None |
| 11295 | REGISTRY | None | None |